DMC Services

Data Monitoring Committee (DMC)

Independent DMC oversight supported by a 1500+ expert member network

Advarra DMC services provide experienced, independent management and the expertise to oversee any therapeutic area.

20+ Years Unmatched Experience in DMC Management

Advarra has the experts and the expertise to assemble independent DMCs within any therapeutic area, create project plans, and provide ongoing management of your DMC. Our goal is to facilitate DMC operations by providing our sponsors with the independence from DMC operations required by regulatory authorities, through seamless integration with our sponsor and CRO trial teams.

Faster Committee Kickoff Timelines

From member identification and contracting within our 1,500+ network of clinical and biostatistical experts to creating the DMC charter and holding the committee kickoff meeting, Advarra DMC services have the fastest average start-up times in the industry.

Collaboration and Customer Satisfaction

By taking a proactive approach to facilitating communication between all key stakeholders, we address concerns early on to avoid surprises and minimize the chances of delays. Advarra’s DMC team helps prevent unexpected delays that may impact DMC oversight, relieving study team administrative burden and delighting our customers.

Global Regulatory Compliance

Advarra’s DMC project managers ensure compliance with US FDA and EU EMA guidelines, as well as any applicable country-specific requirements, by bringing their experience, objectivity, and independence to all aspects of DMC oversight.

Technology that Protects Trial Data

Advarra’s Safety Oversight Administration and Reporting (SOAR) Platform provides role-based access to confidential DMC data reports and documentation within an audit-ready environment that meets all major international data privacy regulations.

Flexible Support Model for CROs

Advarra accommodates the unique needs of CROs by allowing you to outsource only what additional services are needed, whether it’s administrative services only or full-service outsourcing.

The Advarra Difference

Committee Setup and Charter Development

Member Identification: Advarra’s DMC team will identify and qualify potential members for sponsor approval, as well as contract the selected members.
Expertise: Advarra’s global network of 1,500+ experts across all therapeutic areas allow Advarra to identify members with the qualifications to oversee even the most targeted therapeutic indications.
Charter Development: Your DMC project manager will collaborate with your clinical team to develop a charter that meets the needs of your study and adheres to all applicable regulatory guidelines, including US FDA and EU EMA.
Rapid Start-up: Advarra achieves the industry’s fastest average time from project engagement to DMC formation thanks to our existing relationships with experts, preventing delays to the start of DMC oversight for your clinical trial.

Excellence in Execution

Collaborative Project Management: Your DMC project manager acts as a single point of contact to streamline communication between committee members, sponsor, and CRO trial team to provide ongoing support throughout the duration of the trial.
Meeting Facilitation: Your DMC project manager will schedule meetings, drive timelines between stakeholders (to ensure meeting deliverables are on time), take meeting minutes, obtain the signed DMC recommendation, and send the results to sponsors.
One-Day Recommendation Turnaround: Sponsors receive DMC recommendations within one business day following each data review meeting.

Safety, Security, Integrity

Secure Data Exchange Management: Advarra’s Safety Oversight Administration and Reporting (SOAR) Platform is a secure platform that houses all DMC documentation for the duration of your clinical trial. SOAR allows for role-based access within the platform for blinded and/or unblinded roles, and ensures inspection readiness for all DMC data and operations.
_{The SOAR platform is compliant with all applicable regulations, including HIPAA, GDPR, PIPEDA, and FDA Part 11.}
Unbiased and Independent: As a leading global review services provider, Advarra ensures that committee members, committee proceedings, and recommendations regarding trial continuation are independent from those conducting the trial, removing the potential for influence or bias.

The Advarra Difference

Committee Setup and Charter Development

Member Identification: Advarra’s DMC team will identify and qualify potential members for sponsor approval, as well as contract the selected members.
Expertise: Advarra’s global network of 1,500+ experts across all therapeutic areas allow Advarra to identify members with the qualifications to oversee even the most targeted therapeutic indications.
Charter Development: Your DMC project manager will collaborate with your clinical team to develop a charter that meets the needs of your study and adheres to all applicable regulatory guidelines, including US FDA and EU EMA.
Rapid Start-up: Advarra achieves the industry’s fastest average time from project engagement to DMC formation thanks to our existing relationships with experts, preventing delays to the start of DMC oversight for your clinical trial.

Excellence in Execution

Collaborative Project Management: Your DMC project manager acts as a single point of contact to streamline communication between committee members, sponsor, and CRO trial team to provide ongoing support throughout the duration of the trial.
Meeting Facilitation: Your DMC project manager will schedule meetings, drive timelines between stakeholders (to ensure meeting deliverables are on time), take meeting minutes, obtain the signed DMC recommendation, and send the results to sponsors.
One-Day Recommendation Turnaround: Sponsors receive DMC recommendations within one business day following each data review meeting.

Safety, Security, Integrity

Secure Data Exchange Management: Advarra’s Safety Oversight Administration and Reporting (SOAR) Platform is a secure platform that houses all DMC documentation for the duration of your clinical trial. SOAR allows for role-based access within the platform for blinded and/or unblinded roles, and ensures inspection readiness for all DMC data and operations.
_{The SOAR platform is compliant with all applicable regulations, including HIPAA, GDPR, PIPEDA, and FDA Part 11.}
Unbiased and Independent: As a leading global review services provider, Advarra ensures that committee members, committee proceedings, and recommendations regarding trial continuation are independent from those conducting the trial, removing the potential for influence or bias.

Advarra’s DMC Experts

Barbara Schneider, PhD, MBA

Executive Director, DMC/EAC Services

Dr. Barbara Schneider heads Advarra’s independent services for DMCs and endpoint adjudication committees (EACs), which have provided trusted safety oversight for clinical trials since 2002. Prior to joining Advarra, Dr. Schneider was the founder and CEO of Watermark Research Partners. Watermark was one of the first companies to provide independent data safety monitoring board (DSMB) services and endpoint adjudication to the clinical trial industry. (Watermark joined Advarra in 2021.)

James Riddle, MCSE, CIP, CPIA, CRQM

Senior Vice President, Global Review Operations

James Riddle brings 25+ years of experience providing support to the clinical research community and oversees all of Advarra’s global review services including IRB, IBC, DMC, EAC. In this role, he helps sponsors, CROs, and research sites advance clinical research with a mission to improve human health. His expertise includes developing and operationalizing processes for maximum efficiency, client satisfaction, and participant protection; development and implementation of technology solutions; and efficient, compliant operation of large clinical research review programs. Riddle is a regular speaker at industry events and has written abundantly on research compliance and efficiency topics. He is also a member of CTTI, NWABR, SASI, and PRIM&R.

Tina Tran

Strategic Services Provider, DMC/EAC

Tina Tran comes with a wealth of knowledge in all things Data including study design, statistical methodology, biostatistics, data management, eCRF design/specs, electronic data capture (EDC), EACs, and DMCs. Tran brings her prior experience from the University of Washington, Axio Research, Cytel Statistics and Data Corporation (SDC), and Unlearn AI. Tran received her Bachelor of Science from the University of Washington.

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Frequently Asked Questions

Explore our comprehensive FAQ page for detailed answers to questions about our IRB, IBC, DMC, and EAC services.

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